TENS/EMS device (GUSE01)

The GUSE01 is a battery-powered TENS/EMS device that delivers pulsed electrical currents through self-adhesive electrodes to stimulate nerves and muscles. TENS mode provides temporary pain relief for sore and aching muscles from exercise or normal activities. EMS mode stimulates healthy muscles to improve performance, with an integrated relax function that produces a massage-like sensation.

The subject device has two output channels with adjustable pulse intensity and multiple pre-programmed modes (4 acute TENS, 5 chronic TENS, 8 EMS training, 5 EMS relax). Key parameters include biphasic rectangular/spike waveforms, frequency range 2–120 Hz, pulse width 50–400 µs, and maximum output voltage/current of 100 Vpp at 500 Ω and 200 mA. Minor differences from the predicate include regulated current versus voltage control, alternating versus synchronous channel activation, and slightly different output specifications that do not adversely affect safety or effectiveness.

IEC 60601-1 (general requirements for basic safety), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-1-11 (home healthcare environment), IEC 60601-2-10 (nerve and muscle stimulators), and ISO 10993 (biocompatibility). Compliance with 21 CFR 898 was also demonstrated.

The subject device is substantially equivalent to the predicate HIVOX SEM44/SEM44-1 because both devices operate on the same fundamental principle of generating and transmitting electrical pulses to stimulate peripheral nerves and muscles through skin electrodes. Both are Class II OTC devices with the same product codes and FDA regulation. Although the GUSE01 has some different output parameters and waveform shapes, all differences have been tested and shown to not raise safety or effectiveness concerns per IEC standards. A reference device supports the massage-like sensation claim with comparable parameters.